PThe Position is Hybrid, not 100% remote (many projects will require on-site presence) /ppbPosition Description : /b /ppAs the Associate Director within the Quality Compliance and Regulatory Practice Area at CAI, you will serve as both a strategic leader and subject matter expert. You will be responsible for building, expanding, and leading the Practice Area function across Europe, ensuring excellence in service delivery, operational readiness, and execution. /ppThis role involves active participation in business development activities, including marketing, direct sales, and sales support across various regions in Europe. You will also play a key role in designing and implementing systems, processes, and initiatives that drive sustainable business growth. /ppThe Associate Director will report directly to the Practice Area Leader (PAL) for Quality, Compliance, and Regulatory Affairs (QCR). /ppbSpecific responsibilities include : /b /pulliAs a leader, work collaboratively with CAI agents to sell QCR services and deliver strategic project work. /liliLeverage your professional network to attract new business opportunities, generate leads, and secure assignments for consultants through proactive and targeted sales efforts. /liliEngage in industry forums, speaking engagements, article writing, and participation in professional society committees; support the development of standards or guidance documents within these groups. /liliPossess a network of industry contacts who would recognise you as an expert in Quality and Compliance. /liliCreate and contribute to content that supports industry-leading approaches, enhancing CAI’s website and marketing materials. /liliConsult clients in the areas of Quality, Regulatory, and Compliance. /liliProvide significant support to the PAL with respect to quality systems, knowledge management, service definition, and delivery in your area of expertise. /liliFulfil Quality, Regulatory, and Compliance roles while managing client relationships for a portfolio of products, ensuring alignment with project schedules and stakeholder expectations. /liliEngage in strategic project work that opens the door to broader team deployments or complements larger initiatives with specialised expertise. /liliBuild and maintain strong relationships with EU regulatory authorities and other relevant stakeholders to ensure access and influence. /liliDevelop and mentor CAI agents through structured professional development plans and initiatives. /li /ulpbPosition Requirements : /b /pulliWork Environment : Hybrid role with on-site presence required as needed across European client sites. /liliEducation : Bachelor’s, Master’s, or PhD in Biotechnology, Chemistry, Pharmaceutical Manufacturing Technology, Industrial Pharmaceutical Science, Pharmaceutical Technology and Quality Systems, Engineering, or a related scientific discipline, combined with relevant industry experience. /li /ulpbExperience : /b /pulliMinimum of 10 years of experience in the life sciences industry (Pharma, Medical Device, Biotech, etc.), with a proven track record of leading or collaborating effectively within cross-functional teams. /liliIn-depth knowledge of cGMP systems, Quality Assurance, regulatory affairs, pharmaceutical manufacturing, and testing, with direct experience in manufacturing environments. /liliPrior experience in sterile manufacturing, biotechnology, medical devices, and / or Cell and Gene Therapy is highly advantageous. /liliDemonstrated technical leadership in the development and implementation of Quality Management Systems (QMS). /liliLeadership Mentorship : Leads and mentors teams, influencing peers and stakeholders to achieve results. /liliCommunication Skills : Communicates clearly, writes technical documents, presents business ideas, and fosters collaboration. /liliDecision-Making : Makes sound, timely decisions that benefit the team and organisation. Gathers relevant information, asks insightful questions, and collaborates to identify optimal solutions. /liliBusiness Acumen : Delivers quality work, identifies improvement opportunities, and simplifies processes. /liliDrive : Demonstrates initiative, self-management, and strong organisational skills. /liliRegulatory Data Compliance Expertise : Knowledgeable in EU and international data regulations, ensuring integrity, security, and compliance. /liliTechnical cGMP Expertise : Skilled in cGMP environments, covering manufacturing practices and quality systems. /liliLearning Agility Problem-Solving : Adaptable, resolves issues effectively, plans independently, and works well in teams. /liliPositive Influence : Identifies and addresses problems, takes initiative, seeks feedback, and drives continuous improvement. /liliRelationship Building : Maintains strong relationships at all levels, shares knowledge, and collaborates constructively. /li /ulpbOther Requirements : /b /pulliAble to travel domestically and internationally across Europe as required /liliAble to work in the EU without visa sponsorship now or in the future /li /ulp133,000 - €153,000 a year The Position is Hybrid, not 100% remote (many projects will require on-site presence) Position Description : As the Associate Director within the Quality Compliance and Regulatory Practice Area at CAI, you will serve as both a strategic leader and subject matter expert. You will be responsible for building, expanding, and leading the Practice Area function across Europe, ensuring excellence in service delivery, operational readiness, and execution.This role involves active participation in business development activities, including marketing, direct sales, and sales support across various regions in Europe. You will also play a key role in designing and implementing systems, processes, and initiatives that drive sustainable business growth.The Associate Director will report directly to the Practice Area Leader (PAL) for Quality, Compliance, and Regulatory Affairs (QCR). Specific responsibilities include : /pulliAs a leader, work collaboratively with CAI agents to sell QCR services and deliver strategic project work. /liliLeverage your professional network to attract new business opportunities, generate leads, and secure assignments for consultants through proactive and targeted sales efforts. /liliEngage in industry forums, speaking engagements, article writing, and participation in professional society committees; support the development of standards or guidance documents within these groups. /liliPossess a network of industry contacts who would recognise you as an expert in Quality and Compliance. /liliCreate and contribute to content that supports industry-leading approaches, enhancing CAI’s website and marketing materials. /liliConsult clients in the areas of Quality, Regulatory, and Compliance. /liliProvide significant support to the PAL with respect to quality systems, knowledge management, service definition, and delivery in your area of expertise. /liliFulfil Quality, Regulatory, and Compliance roles while managing client relationships for a portfolio of products, ensuring alignment with project schedules and stakeholder expectations. /liliEngage in strategic project work that opens the door to broader team deployments or complements larger initiatives with specialised expertise. /liliBuild and maintain strong relationships with EU regulatory authorities and other relevant stakeholders to ensure access and influence. /liliDevelop and mentor CAI agents through structured professional development plans and initiatives.________________________________________ Position Requirements : /liliWork Environment : Hybrid role with on-site presence required as needed across European client sites. /liliEducation : Bachelor’s, Master’s, or PhD in Biotechnology, Chemistry, Pharmaceutical Manufacturing Technology, Industrial Pharmaceutical Science, Pharmaceutical Technology and Quality Systems, Engineering, or a related scientific discipline, combined with relevant industry experience.Experience : /liliMinimum of 10 years of experience in the life sciences industry (Pharma, Medical Device, Biotech, etc.), with a proven track record of leading or collaborating effectively within cross-functional teams. /liliIn-depth knowledge of cGMP systems, Quality Assurance, regulatory affairs, pharmaceutical manufacturing, and testing, with direct experience in manufacturing environments. /liliPrior experience in sterile manufacturing, biotechnology, medical devices, and / or Cell and Gene Therapy is highly advantageous. /liliDemonstrated technical leadership in the development and implementation of Quality Management Systems (QMS).________________________________________ Skills / Competencies : /liliLeadership Mentorship : Leads and mentors teams, influencing peers and stakeholders to achieve results. /liliCommunication Skills : Communicates clearly, writes technical documents, presents business ideas, and fosters collaboration. /liliDecision-Making : Makes sound, timely decisions that benefit the team and organisation. Gathers relevant information, asks insightful questions, and collaborates to identify optimal solutions. /liliBusiness Acumen : Delivers quality work, identifies improvement opportunities, and simplifies processes. /liliDrive : Demonstrates initiative, self-management, and strong organisational skills. /liliRegulatory Data Compliance Expertise : Knowledgeable in EU and international data regulations, ensuring integrity, security, and compliance. /liliTechnical cGMP Expertise : Skilled in cGMP environments, covering manufacturing practices and quality systems. /liliLearning Agility Problem-Solving : Adaptable, resolves issues effectively, plans independently, and works well in teams. /liliPositive Influence : Identifies and addresses problems, takes initiative, seeks feedback, and drives continuous improvement. /liliRelationship Building : Maintains strong relationships at all levels, shares knowledge, and collaborates constructively.________________________________________ Other Requirements : /liliAble to travel domestically and internationally across Europe as required /liliAble to work in the EU without visa sponsorship now or in the future /li /ulpJ-18808-Ljbffr /ppJ-18808-Ljbffr /p #J-18808-Ljbffr